Table 2 Therapeutic options for NMOSD-related relapses
From: Neuromyelitis optica spectrum disorders: from pathophysiology to therapeutic strategies
Drug | Study design | Study phase / ClinicalTrials.gov Identifier(status 01/2021) | Number of patients (randomization) | NMOSD serostatus | Follow-up | Disability (EDSS stabilization or improvement) | Safety concerns |
|---|---|---|---|---|---|---|---|
Bevacizumab | Single-center, Open Label Trial (USA) | Phase 1 add-on therapy (completed) NCT01777412 | 10 | AQP4-ab + (n = 6) and – (n = 4) | 91 days after admission | at baseline: 3.5 (2–7) at FU: 3 (1.75–6.5) | UTI that required hospitalization and improved with specific Tx |
Ublituximab | Single-center, Open Label Trial (USA) | Phase 1 add-on therapy (completed) NCT02276963 | 6 (5 completed the study) | AQP4-ab + | 90 days after admission | at baseline: 6.5 (5.25-7.5) at FU (n = 3): 4 (2–8) | Leukopenia (n = 1) headache and body ache (n = 3) |
NPB-01 | Single-center, Open Label Trial (Japan) | Phase 2 add-on therapy (completed) NCT01845584 | 7 | AQP4-ab + | Time frame: 29 days | NA | NA |
HBM 9161 | Non-randomized, open label, dose exploration study (China) | Phase 3 study (Active, recruiting) NCT04227470 | 12 (estimated enrollment) | AQP4-ab + | Time frame: 189 days | NA | NA |
Immunoadsorption or Plasma Exchange | Prospective, Multicenter, Single-blind, Randomized study (China) | Phase 2 study (not yet recruiting) NCT04064944 | 144 (estimated enrollment) | AQP4-ab + | Time frame: 4 weeks after the last treatment | NA | NA |